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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1455

SK Chemical Co., Ltd.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: (3S,6S)-3,6-dimethy1-1,4-dioxane-2,5-dione, (3R,6R)-3,6-dimethyl-1,4-dioxane-2,5-dione, 1,6-diisocyanatohexane and 1,3-propanediol copolymer
Notifier: SK Chemical Co., Ltd.
Manufacturer/Supplier: SK Chemical Co., Ltd.
Intended Use: As a component in the manufacture of articles intended to contact food, except for use in contact with infant formula and breast milk (see Limitations and Specifications).
Limitations/Specifications: The FCS is intended to contact all types of food under Conditions of Use C through G, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 10, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 513 kb)
FDA Decision: Finding of No Significant Impact (FONSI)